ITMCTR2200006635尚未招募4 期
To evaluate the efficacy and safety of Bailui Granule in the treatment of acute pharyngitis (wind-heat syndrome).
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(1) In accordance with the Western medicine diagnosis of acute pharyngitis;
- •(2) TCM syndrome differentiation is wind-heat syndrome;
- •(3) The duration of the disease is less than 48 hours (here defined as the time between the patient's appearance of acute pharyngitis symptoms such as sore throat and pharyngeal redness and swelling is less than 48 hours);
- •(4) armpit temperature =38.5?;
- •(5) VAS score of sore throat =4;
- •(6) Age 18-65 (including 18 and 65), both genders;
- •(7) Voluntarily participate in the clinical trial, give informed consent and sign the informed consent form.
排除标准
- •1) chronic pharyngitis;
- •(2) Pharyngeal symptoms or inflammation caused by pneumonia, COVID-19, bronchitis, suppurative tonsillitis, or measles, scarlet fever, influenza, granulocytosis, infectious mononucleosis, leukemia, acute carotid arteritis;
- •(3) white blood cell count >11.0×109/L or neutrophil percentage > 80%;
- •(4) had used any Chinese or western drugs for acute pharyngitis, including drugs for relieving sore throat (such as traditional Chinese medicine preparations, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.);
- •(5) Liver function ALT and AST exceeded the upper limit of the normal reference value 1.5 times or Scr exceeded the upper limit of the normal reference value;
- •(6) Complicated with serious diseases of major organs or systems such as heart, brain, liver, kidney, respiratory system and blood system, such as acute myocardial infarction, acute cerebral infarction, viral hepatitis and hemophilia;
- •(7) Allergic constitution, if there is a history of allergy to two or more drugs or food, or allergic to test drugs (including positive drugs and emergency drugs) or their ingredients and excipients;
- •(8) women who are pregnant or planning to become pregnant, breastfeeding women, patients of reproductive age who are unable or unwilling to use adequate contraception during the trial period, or their spouses who are unwilling to use contraception;
- •(9) Suspected or had a history of alcohol dependence or drug abuse;
- •(10) having an intellectual or mental handicap;
- •(11) Participated in or is participating in clinical trials of other drugs or medical devices within one month;
- •(12) According to the judgment of the investigator, there are other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the work environment and unstable living environment, which are likely to cause loss of follow-up.
研究者
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